There has been a marked increase in the use of disposable medical implements, particularly medical delivery or collection implements, such as hypodermic needles/syringes or evacuated blood collection tubes Typically, such medical implements include relatively elongate piercing elements for administering a medication or withdrawing a fluid. Such piercing elements include, inter alia, pointed needle cannulae or blunt ended cannulae.
Exposure to blood borne pathogens is a recognized hazard by anyone associated with the medical arts. As a result of this recognition, numerous protocols for the use of piercing elements such as needles have been developed and are practiced. The problem of transmission of blood borne pathogens not only exists for the physician, nurse or phlebotomist using the needles, but also for support workers all through the hospital. Since most needles in use today are single-use and disposable, hospital service personnel are at risk from needles that are not properly handled by the users. A definite need has developed for ways to safely and conveniently handle and transport such implements, both during interim use of the implement and after use is completed, so that disposal can be effected while reducing the risk of exposing any person handling the used implements to injury, infection or disease by puncture or contact with a used needle.
In today's medical facilities, then, a wide variety of disposable needle devices are routinely used to administer medication by injection and intravenous ("I.V.") procedures, or for intravenous collection or withdrawal procedures such as blood collection, Either interim the completion of a procedure or once an injection is given, a blood sample drawn, or an I.V. needle removed from a patient, both the needle and/or syringe or tube used in the procedure may be contaminated and must be either handled or disposed of in a safe manner. The problem is particularly heightened because competent medical personnel will not normally leave a patient unattended immediately after administering an I.V. procedure in order to search out disposal facilities for the used medical implement. Consequently, while the nurse or physician is attending to the patient, unsheathed contaminated needles have been momentarily placed on bedside tables, the used needles have been placed on the patient's bedding, and bed mattresses have even been used as a type of "pincushion" to temporarily hold the contaminated needle.
The needle use protocols previously mentioned generally dictate in detail when and how a needle will be used and how it should be disposed of. The problem with many protocols for handling needles is that the protocols often require users to perform additional steps in a procedure With the pressure of time and simple carelessness, certain practices regarding handling of used needles are sometimes disregarded and injuries may occur.
For instance, it has been a practice to break or cut a piercing element such as a needle after use and before transport to ultimate disposal so as to eliminate the sharp end point, thereby reducing the risk of puncture, scratching or other injury which might result from handling. However, the very act of breaking or cutting the needles may expose the medical personnel to accidental puncture during the breaking or cutting operations. In addition, residual medication or blood in the needle or the syringe can splatter onto the person or his clothes, and potentially harmful fumes from the residual medication could be inhaled as a result of the so-called aerosol effect. Furthermore, the blades of the cutting tool might possibly serve as a breeding ground for germs, bacteria and other disease-causing micro-organisms to which an unsuspecting person cutting the needle could be unnecessarily exposed. Recently, an even greater danger has been recognized in connection with the handling and disposal of used needles as well as other sharp medical implements. It is now believed that certain diseases, most notably Hepatitis B, can be transmitted by covert percutaneous --i.e., by merely contacting the contaminated needle or implement.
While the used needle portion of a needle/medical implement combination presents the most significant risk of injury or injection through accidental puncture or scratching of a person's skin, the used implement part may also present a risk of infection. For example, a used implement such as a syringe, a blood collection shield, or the like can contain residual blood or medication which, if exposed to a person's skin, may be absorbed topically (particularly if a cut or break in the skin is present) and may cause a serious internal infection or other reaction. As a result of the foregoing dangers, it is preferred current practice to dispose of such devices intact, without dismantling them.
One approach for shielding a needle assembly to address the concerns voiced above might entail providing the needle assembly with a pivotable barrier assembly for protecting the elongate piercing element, inclusive of pointed needle cannulae or blunt ended needle cannulae, from inadvertent touch contact. The barrier assembly would include, for instance, a shield displaying an open end, a closed end, and an enclosing sidewall portion having a slot extending from the open end toward the closed end. In a first position, the shield is rotated away from the piercing element so that it is exposed for use. A second position is provided wherein the shield is rotated so that it substantially encloses the piercing element therein to prevent inadvertent touch contact, particularly obstructing access to the tip of the piercing element.
In this approach, numerous closing and/or locking assemblies may be provided for use of the shield. Where locking assemblies are employed, typically the shield will be securely locked in the closed position following use of the piercing element. However, in instances where it is desired to be able to reuse the piercing element, the shield may be provided with a closing assembly capable of repeated opening, allowing the shield to be releasably retained in the second position pending interim use of the implement, but structured such that the shield may be repeatedly rotatated out of the closed position. This provides a user with the ability to reuse the piercing element at will.
In either of the various locking assemblies or closing assemblies, it is typical that piercing elements will be shipped with the needle shield retained in an open position. In order to protect the piercing element from contamination during transit, a conventional cap may be placed over the piercing element so as to protect piercing element. While this is both a safe and effective approach, it would be advantageous to structure the barrier assembly with some type of a secondary sheathing element utilizable to protect the needle during shipment or prior to use, which secondary element would also provide a second degree of protection against an inadvertent touch contact with the piercing element following use, and which secondary element would also serve to permanently lock a releasable shield in place when disposal of the implement is desired..
U.S. Pat. No. 4,872,552 to Unger is directed to safety packaging for a hypodermic syringe. The device of Unger includes a pivotable shield 54 with an axially directable component 68 configured to allow a user to physically pierce the tip 16 of the needle to safeguard the user against inadvertent needlestick. An external tube-like sealing device 10 is provided for snug engagement with the cylindrical end of the syringe 18 in an effort to effect hermetic sealing of the entire structure. As depicted in the Unger reference, no contact is made between the device 10 and the other components of the device, exclusive of the syringe 18 itself.